The epinephrine auto injector product Auvi‑Q has been recalled, announced pharmaceutical company Sanofi U.S. on Oct. 28, 2015. The recall affects all Auvi-Q currently on the market, including both .15 mg and .3 mg strengths.
The voluntary recall occurred due to concerns that the products have the potential for inaccurate dosage delivery. Since the product is used to treat life-threatening allergic reactions, an inaccurate dose could have significant health consequences, including death.
In addition to the recall, “we have temporarily stopped manufacturing,” said Dr. Paul Chew, Sanofi’s global chief medical officer, in a video release.
Sanofi says that they have received 26 as-yet-unconfirmed reports of suspected device malfunctions in the U.S. and Canada. There have been no fatal outcomes among the cases, but patients have reported symptoms of underlying sensitivity reaction.
How to Report Adverse Events and Return Recalled Auvi-Q Devices
Customers are being asked to contact their physician or health care provider if they have experienced any issues connected to the use of Auvi-Q.
Sanofi is also asking customers to contact their health care provider to request a prescription for an alternate epinephrine auto-injector. Reimbursement for out-of-pocket costs for the purchase of replacement auto-injectors will be provided by Sanofi with proof of purchase.
Additionally, adverse events or quality problems can be reported in one of two ways:
- Call Sanofi US at 1‑800‑666‑1630, Option 2.
- Contact the Food and Drug Administration’s Med Watch Program: fax 1‑800‑FDA‑0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852‑9787, or on the MedWatch website
Sanofi is arranging for the return and reimbursement of all recalled products. They are notifying affected parties, which include distributors and customers including doctors and pharmacies.
FAQs about the recall can be found online at www.Auvi-Q.com. Customers can also call 1‑877‑319‑8963 or 1‑866‑726‑6340, Monday through Friday from 8 a.m. to 8 p.m if they require assistance with returning Auvi-Q devices.